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Completed

NCT Number: NCT06393517

A Study to Learn How Different Forms of the Study Medicine Called PF-06954522 Are Taken up Into the Blood in Healthy Adults

The purpose of this study is to compare three finished products of PF-06954522 in terms of the uptake into the blood stream.

This study is seeking participants who are:

- Healthy male or female participants aged 18 years or older.

All participants in this study will receive PF-06954522 once by mouth. The participants may receive different tablets by mouth for PF-06954522.

The study will compare experiences of people receiving three different products of PF-06954522. This will help understand how much PF-06954522 is taken up into the blood for each product given.

Participants will take part into the study for about 77 days. During this time participants will have to stay onsite for 21 days. There will be one follow up (by telephone) study visit.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit, New Haven, Connecticut, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female participants of non-childbearing potential aged 18 years or older who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and electrocardiograms.
  • Body mass index of 16-32 kg/m2; and a total body weight >50 kg (110 lbs).

Exclusion criteria

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
  • Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2, or participants with suspected MTC per the investigator's judgement.
  • Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
  • Use of any prohibited prior/concomitant medication(s).
  • A positive urine drug test at screening or admission.

Treatment and study plan

PF-06954522 IR (Formulation 1)

Drug

Participants to receive a single dose (Dose Level 1 and 2) of PF-06954522 Formulation 1 by mouth

PF-06954522 MR (Formulation 2)

Drug

Participants to receive a single dose (Dose Level 1 and 2) of PF-06954522 Formulation 2 by mouth.

PF-06954522 MR (Formulation 3)

Drug

Participants to receive a single dose (Dose Level 1 and 2) of PF-06954522 Formulation 3 by mouth

Primary outcomes

  1. Area Under the Curve from time zero to extrapolated infinite time (AUCinf) of PF-06954522 to evaluate the relative bioavailability of three PF-06954522 formulations administered in the fasted state.

    Time frame: 0 hours (pre-dose) to 72 hours (extrapolated to infinite time) post PF-06954522 dose in each period

  2. Maximum Observed Plasma Concentration (Cmax) of PF-06954522 to evaluate the relative bioavailability of three PF-06954522 formulations administered in the fasted state.

    Time frame: 0 hours (pre-dose) to 72 hours post PF-06954522 dose in each period

Secondary outcomes

  1. Number of Participants with Treatment-Emergent Adverse Events (AEs)

    Time frame: From baseline up to 49 days after PF-06954522 dose in Period 1 Day 1

  2. Number of Participants with Laboratory Test Abnormalities

    Time frame: From baseline up to 72 hours after PF-06954522 dose in each period

  3. Number of Participants with Summary of Post-Baseline Vital Signs Data

    Time frame: From baseline up to 72 hours after PF-06954522 dose in each period

  4. Number of Participants who met Defined Electrocardiogram (ECG) Criteria

    Time frame: From baseline up to 72 hours after PF-06954522 dose in each period

  5. Area Under the Curve from time zero to extrapolated infinite time (AUCinf) of PF-06954522 to evaluate the relative bioavailability of two PF-06954522 formulations administered in the fed state compared to fasted state.

    Time frame: 0 hours (pre-dose) to 72 hours (extrapolated to infinite time) post PF-06954522 dose in each period

  6. Maximum Observed Plasma Concentration (Cmax) of PF-06954522 to evaluate the relative bioavailability of two PF-06954522 formulations administered in the fed state compared to the fasted state.

    Time frame: 0 hours (pre-dose) to 72 hours post PF-06954522 dose in each period

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A PHASE 1, OPEN-LABEL, RANDOMIZED, 5-PERIOD, 6-SEQUENCE, CROSSOVER STUDY TO COMPARE THE SINGLE-DOSE PHARMACOKINETICS OF IMMEDIATE-RELEASE AND MODIFIED-RELEASE FORMULATIONS OF PF-06954522 ADMINISTERED ORALLY TO HEALTHY ADULT PARTICIPANTS

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 1, 2024
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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